EP0002607A1

EP0002607A1 - A device for making implants in the human body

Info

Publication number: EP0002607A1
Application number: EP78300804A
Authority: EP
Inventors: Philip O.(deceased) legally represented by Bates H. Richard Littleford
Original assignee: Littleford Philip O(deceased) Legally Represented By Bates H Richard
Current assignee: Littleford Philip O(deceased) Legallyrepresented
Priority date: 1977-12-13
Filing date: 1978-12-13
Publication date: 1979-06-27
Also published as: AU519365B2; CA1108702A; DE2853809C2; DE2853809A1; EP0002607B1; US4166469A; AU4247178A

Abstract

A device is disclosed for implanting a pacemaker electrode within a patient with a minimal amount of incision. The device comprises an introducer sleeve 56 which is severed or is severable along the length thereof. The sleeve is insertable into the subclavian vein through a prior incision made by needle. The introducer sleeve may be introduced through the needle or on the outer surface of a needle, or through the use of a guide wire passed through the internal portion of the needle after the needle is removed. The electrode tip 42 is inserted through the introducer sleeve to enter the vein 16 of the patient. The introducer sleeve is withdrawn from the patient while the electrode lead 20 is moved through a cut or line of weakness 64 in the sleeve wall along the entire length thereof to remove the sleeve over the connector plug 30 of the electrode.

Description

This invention relates to the making of implants, e.g. of electrodes, in the human body and to a device for assisting the making of such implants and eliminating the need for extensive surgery, or for reaching sites not accessible by surgical techniques.
The field of medical technology has experienced unprecedented developments in the last several decades. Some of the most dramatic advances in the medical field have occurred in the understanding and control of the human heart. The development of the pacemaker has solved some of the heretofore unsolvable problems of heart disease and has extended the lives of thousands of patients. Presently, a surgical implant of a pacemaker and pacemaker electrode requires approximately 1-2 hours of surgical time. This surgical procedure comprises sectioning through the tissue layers of the patient down to the cephalic vein. An incision is made in the cephalic vein and the electrode tip is inserted through the incision and directed toward the heart. Further insertion of the electrode through the cephalic vein enables entry of the electrode tip into the right ventricle of the heart. The electrode is then tied to the body tissue and a second surface incision is made for receiving the pacemaker pulse generator. The electrode is connected to the pulse generator by a special plug-receptacle combination. The pacemaker is then implanted within the patient.
The cephalic vein is located beneath the layers of the pectoralis muscle on the chest wall. Many times a large physical incision and a considerable amount of dissection is required to isolate the cephalic vein. hot infrequently, the cephalic vein is too small to accommodate the size of pacemaker electrodes currently available. In such a case, more extensive dissection must be made in following the cephalic vein to its origin. The cephalic vein extends beneath the clavicle, running ultimately to the subclavian vein. The subclavian vein is presently inaccessible by known surgical techniques to direct surgical insertion of a permanent electrode.
Others in the prior art have inserted temporary electrodes directly into a patient through the use of a surgical needle. The needle is introduced into a patient and the electrode tip is inserted through a centre passage in the needle to enter an organ of the patient. The other end of the electrode is temporarily connected to an electronic device or the like.
Pacemaker electrodes generally have an electrode tip and electrode plug on opposite ends thereof. Accordingly, a permanent pacemaker electrode cannot be inserted through a needle since the needle cannot be removed over the electrode plug. The electrode cannot be electrically connected to the electrode plug by soldering or other means after the electrode is inserted since the electrode must be sterile.
The present invention seeks to provide a device for quickly and efficiently inserting a permanent pacemaker electrode into the heart cavity without sectioning to a vein of a patient.
The present invention will be best understood by reference to a method of inserting a permanent electrode into an internal organ of a patient wherein the electrode has an electrode tip at one end and a connector plug at the other end. The method is particularly suitable for implanting a pacemaker within a patient wherein the pacemaker comprises an encapsulated pulse generator haviag a receptacle for receiving the connector plug of the electrode. The method includes inserting a needle through the skin of the patient to puncture the internal organ of the patient. An introducer sleeve is introduced within the patient to communicate with the puncture in the internal organ of the patient. The electrode tip is introduced through the introducer sleeve to enter the organ of the patient. The introducer sleeve is then removed from the patient through a severing in the sleeve wall of the introducer sleeve along the length thereof.
The introducer sleeve may be introduced in one of three ways. First, the introducer sleeve may be inserted through the needle puncturing the internal organ leaving the introducer sleeve communicating with the internal organ upon removing the needle. Second, the introducer sleeve may be inserted by introducing a guide wire through the needle to enter the internal organ. The needle is then withdrawn and an introducer and the introducer sleeve are inserted over the guide wire to communicate with the puncture in the internal organ. The introducer and guide wire are then removed leaving the introducer sleeve in communication with the internal organ. Third, the introducer sleeve is located on the outer surface of the needle and is inserted into the patient upon inserting the needle into the patient. The needle is then withdrawn leaving the introducer sleeve in communication with the internal organ of the patient.
When the method is applied to implanting a pacemaker, the needle is inserted through the exterior skin of the patient to puncture the subclavian vein of the patient leading directly to the heart. The introducer sleeve is then inserted within the patient to communicate with the puncture in the subclavian vein in one of the aforementioned methods. The electrode tip is guided through the introducer sleeve to enter the subclavian vein of the patient to enter the heart of the patient. The introducer sleeve is then withdrawn from the patient and the electrode is removed from the introducer sleeve through a severing in the sleeve wall along the entire length of the sleeve. The connector plug of the electrode is connected to the receptacle of the encapsulated pulse generator and the pulse generator is implanted into the patjent by conventional surgical treatment.
An important aspect of the invention resides in the apparatus camprising the interrelation of the needle and the introducer sleeve. In general, the introducer sleeve comprises a plastic or fibrous material having a severing in the sleeve wall or a weakening to aid severing along at least the substantial length of the sleeve. The severing means may talc the form of perforations along the entire or a substantial length of the introducer sleeve. In the alternative, the severing means may comprise a complete severing along all but the tip portion of the introducer sleeve. The severing enables the sleeve to be peeled off of the permanent electrode for removing the sleeve over the connector plug at the end of the electrode.
In the first method, .a guide wire is introduced through the internal passage of the needle to enter the internal organ. The needle is withdrawn over the guide wire. An introducer has a central aperture for receiving the guide wire with the introducer sleeve closely fitting on the outer surface of the introducer. The introducer sleeve is placed on the outer surface of the introducer and the introducer is guided into the internal organ of the patient along the guide wire. The guide wire and the introducer are removed leaving the introducer sleeve.
In the second method of inserting the introducer sleeve, the introducer sleeve must be of a size sufficient to be received within an internal diameter of the internal passage of the needle. Accordingly, the sleeve is inserted through passage of the needle into communication with the internal organ.
In a third method, the introducer sleeve closely fits on the outer surface of the inserting needle. As the needle is inserted into the patient, the introducer sleeve is concomitantly inserted into communication with the internal organ. The needle is then removed leavimg the introducer sleeve.
For a fuller understanding of the invention, reference is made to the accompanying drawings, in which:-

Fig. 1 is an elevational view of an apparatus and method for implanting a pacemaker into the patient showing a needle being inserted through the exterior skin to puncture the subclavian. vein to communicate with the heart of the patient;
Fig. 2 illustrates the completed implant of the pulse generator and the pacemaker electrode in the patient;
Fig. 3 is an elevational side view of an introducer used to implant the electrode in the patient;
Fig. 4 is an elevational view of an introducer sleeve for use with the introducer shown in Fig. 3;
Fig. 5 is a front elevational view of a pacemaker pulse generator;
Fig. 6 is a side elevational view of the pulse generator shown in Fig. 5;
Fig. 7 is a view of the pulse generator shown in Figs. 5 and 6 with a pacemaker electrode having an electrode tip and an electrode plug;
Fig. 8 illustrates the first step in a first method of introducing a permanent electrode into an internal organ of a patient wherein a needle punctures an internal vein of the patient;
Fig. 9 illustrates the second step of the first method showing a guide wire being introduced through the needle into the internal vein;
Fig. 10 illustrates the third step in the first method wherein the introducer and the introducer sleeve shown in Figs. 3 and 4 are inserted into fluid communication with the internal vein;
Fig. 11 is the fourth step of the first method wherein the electrode .of Fig. 7 has been inserted through the introducer sleeve and the sleeve is being peeled off of the electrode to remove the sleeve over the plug at the end of the electrode;
Fig. 12 illustrates the first step of a second method of inserting the electrode into the patient wherein the needle is puncturing the internal vein of the patient;
Fig. 13 illustrates the second step of the second method wherein an introducer sleeve is inserted within the needle into fluid communication with the internal vein of a patient;
Fig. 14 illustrates the third step of the second method wherein the electrode is inserted through the introducer sleeve into the internal vein of the patient;
Fig. 15 shows the fourth step of the second method wherein the introducer sleeve is removed from the electrode;
Fig. 16 illustrates the first step of a third method of inserting the electrode into the patient wherein the needle and an introducer sleeve serially enter the internal organ of a patient;
Fig. 17 illustrates the second step of the third method - wherein the electrode is inserted through the introducer sleeve upon removal of the needle;
Fig. 18 illustrates the introducer sleeve of Figs. 16 and 17 which is a variation of the introducer sleeve shown in Fig. 14;
Fig. 19 is a sectional view along line 19-19 in Fig. 18; and
Fig. 20 is a sectional view along line 20-20 in Fig. 18.

Similar reference characters refer to similar parts throughout the several views of the drawings.
Fig. 1 is an elevational view showing the insertion of a needle 12 and a syringe 14 with the needle 12 being inserted through the exterior skin 11 of a patient 10. The needle 12 pierces the subclavian vein 16 which leads directly to the heart 18 of patient 10. The subclavian vein is essentially inaccessible by surgical dissection. The subclavian vein is a large vein and readily receives a permanent pacemaker electrode. The insertion of the needle 12 is the first step in the method of implanting a pacemaker electrode with minimal incision to the patient. This apparatus and method will be described hereinafter.
Fig. 2 is an elevational view of the patient 10 with a pacemaker electrode 20 extending through the subclavian vein 16 to the heart 18. A pacemaker pulse generator 22 is shown implanted within the patient 10. The pulse generator 22 and the pacemaker electrode 20 are more fully shown in Figs. 5-7.
The pulse generator 22 comprises an electronic circuit and power supply encapsulated in a covering 24 having an aperture 26. The pulse generator 22 includes a receptacle shown generally as a jack 28 for receiving a plug 30 of pacemaker electrode 20. The plug 30 comprises a plurality of 0-rings 32 to seal with aperture 26 of covering 24. The pulse generator includes securing means for securing the plug 30 to jack 28 which is shown as a vice screw 34. The plug 30 is inserted within the receptacle jack 28 and the vice screw 34 is rotated for locking the plug 30 therein. A covering cap or plug 36 covers the end of aperture 26.
A connector pin 38 of plug 30 contacts the negative output of the pulse generator 22. A conductor 40 connects the connector pin 38 to an electrode tip 42 to provide a negative signal upon an output from the pulse generator 22. The positive terminal of the pulse generator 22 comprises an upper metallic electrode 44 shown in Figs. 5-7. Although a specific example of the pacemaker pulse generator 22 and electrode 20 are used in this embodiment, it should be understood that the apparatus and method herein disclosed are not limited to such a pacemaker configuration. For example, the invention is compatible for use with an integral or one-piece pulse generator and electrode. The pulse generator 22 and the electrode 20 shown in Figs. 5-7 are merely disclosed for clarifying the exact practice of the apparatus and method.
Fig. 3 illustrates an introducer 46 which is used in a first method of inserting the pacemaker electrode 20 into the patient 10. The introducer 46 includes a through aperture 48 and a generally pointed tip portion 50. The introducer 46 also comprises a reinforced and flared base 52.
Fig. 4 illustrates an introducer sleeve 56 having a through aperture 58, a flared base 62 and a reduced sleeve wall tip 60. The introducer sleeve 56 and more particularly the aperture 58 is designed to closely fit the outer circumference of the introducer 46 with the base 62 abutting base 52 and the tip 60 tapering from the outer circumference of introducer 46. The introducer sleeve 56 also comprises severing means shown generally as 64 comprising a plurality of through apertures along the length of the introducer sleeve 56. The severing means may comprise a plurality of perforations, slots, or other weakening in one or more locations in the sleeve wall for enabling the sleeve to be severable along the length thereof. The severing means 64 may also comprise a precut in the sleeve wall along all or a substantial length of the introducer sleeve 56.
Figs. 8-11 illustrate the first through fourth steps of a first method of inserting the electrode 20 into an internal organ shown as the subclavian vein 16. Fig. 8 illustrates the needle 12 puncturing the exterior skin 11 of the patient 10 to enter the vein 16. A piston 68 of syringe 14 is withdrawn slightly to draw a small quantity of blood from vein 16 to insure that the needle 12 has entered the vein 16. The blood is returned into the vein 16 and the syringe 14 removed from needle 12 as shown in Fig. 9. A guide wire 70 has. a diameter sufficiently small to enter through the internal passage 12A of needle 12. The guide wire is pushed through needle 12 to enter the vein 16 as shown in Fig. 9. The needle 12 is then removed enabling the introducer 46 and the introducer sleeve 56 to be guided along guide wire 70 to enter the vein 16 as shown in Fig. 10. The base 62 of the sleeve 56 abuts base 52 of introducer 46. The length of sleeve 56 is less than the length of introducer 46 as shown in Figs. 3, 4 and 10. The introducer 46 adds mechanical strength to the introducer sleeve 56 during entry in the patient 10. The guide wire 70 and introducer 46 are then removed from the vein 16 leaving the introducer sleeve 56 in fluid communication with the vein 16. The pacemaker electrode tip 42 is inserted into introducer sleeve 56 to enter vein 16. The electrode 20 is pushed until the electrode tip 42 enters the heart 18 as shown in Fig. 1. The sleeve 56 is severed along the severing means 64 and concomitantly withdrawn from the patient 10 leaving the electrode tip 42 within the heart cavity. In the case of the sleeve 56 being precut, the sleeve is merely peeled off at the electrode 20. The electrode plug 30 may then be connected to the pulse generator 22. The pulse generator 22 is then implanted into the patient 10.
Figs. 12-15 show the first four steps of a second method of introducing the electrode 20 into an internal organ of a patient. Fig. 12 illustrates the needle 12 puncturing the external skin 11 to enter the vein 16 in a manner similar to Fig. 8. The piston 68 is withdrawn drawing blood from vein 16 to insure proper entry into the vein 16. The syringe 14 is then removed enabling a sleeve 56A to be inserted within the internal passage 12A of needle 12 to enter the vein 16. The sleeve 56A is substantially tubular and having severing means 64A similar to that shown in Fig. 4. The introducer sleeve 56A does not have an expanded base 62 as in Fig. 4 which enables the needle 12 to be withdrawn over the sleeve 56A leaving the sleeve 56A within vein 16. The electrode tip 42 is inserted through the introducer sleeve 56A into the vein 16 to enter heart 18 as shown in Fig. 14. The sleeve 56A may then be removed by severing along the severing means 64A as shown in Fig. 15. The limitation of the second method shown in Figs. 12-15 is determined by the state-of-the-art size of the electrode tip 42 shown in Figs. 7, 14 and 15. The size of the needle used is determined by the size of the electrode tip 42. Large electrode tips require a large needle which can produce substantial tissue damage. In such a case, the first method shown in Figs. 8-llis preferable since the introduction of the introducer and introducer sleeve 46 and 56 as shown in Fig. 10 merely separates tissue from the original incision by needle 12 rather than cutting of the tissue. Accordingly, a smaller needle is required in the first method shown in Figs. 8-11 than the second method shown in Figs. 12-15.
Figs. 16 and 17 illustrate the first and second steps of a third method of inserting a pacemaker electrode into a vein ₁6. In this embodiment, the introducer sleeve 56B more fully shown in Figs. 18-20 comprises a central through aperture 58B and a tip portion 50B. Figs. 19 and 20 illustrate sectional views of the introducer sleeve 56B showing the relative wall thicknesses at section lines 19-19 and 20-20 in Fig. 18. The severing means 64B in this embodiment comprises a cut extending from the end 62B of introducer sleeve 56 to a region within approximately five millimeters of tip 50B.
The inner aperture 58B of sleeve 56B is selected to closely receive the outer surface 12B of needle 12. The length of introducer sleeve 56B is slightly shorter than the length of needle 12 enabling the needle to make a primary puncture through the external skin 11 of the patient 10 and internal organs prior to entry by the introducer sleeve 56B. The needle 12 and sleeve 56B are inserted into communication with the vein l6 and the needle 12 is withdrawn, leaving the sleeve 56B in communication with the vein 16. The electrode 20 may then be inserted into the vein 16 and the heart 18 by the introducer sleeve 56B as shown in Fig. 17. The connector plug 30 may then be secured to the pulse generator 22 as heretofore described. In this embodiment, the needle required is larger than the method shown in Figs. 8-11, but is generally smaller than the needle required in Figs. 12-14. In this case, the sleeve 56B closely fits on the outer surface 12B of needle 12.
The foregoing has described three distinct methods of inserting the electrode 20 into an internal organ of the patient ₁₀. In each case, an electrode sleeve 56 was used for introducing the electrode 20 into an internal organ of the patient 10. Mechnical strength is given to the introducer sleeve during entry into the patient 10. In the first method, the introducer aids entry of the sleeve. In the second and third methods, the needle aids entry of the sleeve. Accordingly, the introducer sleeve may be made of a lightweight material. The physical characteristics of the sleeve shown in Figs. 4, 18-20 may be adapted to any of the three methods.
In the device of the present invention the severing means which enables the sleeve to be peeled off the electrode may take various forms such as perforations, holes, through cuts, reduced wall thickness and integral cutting agents such as a string moulded into the sleeve.

Claims

1. A device for assisting the implantation of electrodes into the human body comprising an elongate sleeve having along the length thereof, a cut, a line of weakness or other in-built means of severing the sleeve along its length, and means for inserting said sleeve into an incision made in the body, said inserting means comprising a rigid member axially engageable with said sleeve and enabling said sleeve to be inserted into the body through said, incision and to bring the forward end of the sleeve into a desired location within the body, said insertion means being axially removable from said. sleeve after the placement thereof in the desired position, the placed sleeve then enabling the electrode with a lead attached to be passed therethrough into said desired location after which the sleeve may be withdrawn from the body and disengaged from said lead by passing said lead along said cut or along the cut formed by operation of said severing means to sever the sleeve along its length.

2. A device, according to claim 1, wherein the sleeve is thin flexible tube of plastics material.

3. A device according to claim 1 or 2, wherein the sleeve has along its length a line of perforations which provide said line of weakness.

4. A device according to claim 1 or 2, wherein said sleeve has a through cut therein extending substantially the whole length of said sleeve, but stopping short of the forward, end thereof.

5. A device according to any one of the preceding claims, wherein said insertion means comprise a rigid tubular member which mates internally with said sleeve, said tubular member having a length greater than that of said sleeve, whereby the forward of said tubular member projects a short distance from the end of said sleeve when received thereon.

6. A device according to claim 5, wherein said rigid tubular member is a hypodermic needle the external surface of which receives said sleeve.

7. A device according to any one of claims 1-4, wherein said insertion means comprise a rigid tubular member which mates externally with said sleeve.

8. A device according to claim 7, wherein said rigid tubular member is a hypodermic needle the bore of which receives said sleeve.

9. A device according to any one of the preceding claims, wherein said sleeve has a tapered forward end.